Sensorion, le début d’une belle aventure

Sensorion is recruiting a Head of Clinical Operations F/M based on Paris.

Missions

Reporting to the Chief Medical Officer, the Head of Clinical Operations will be responsible for all the aspects of clinical trial delivery, from study set-up to end of study, including all logistical, financial, administrative and organisational aspects.

Main Activities

Responsibility and monitoring of clinical activities:

• Supervise the sites’ selection and qualification in collaboration with the CRO and the Medical department
• Optimization of patients‘ recruitment in clinical studies
• Supervise the creation of specific trial documents, validate them and ensure their implementation, including recruitment plan
• Establish the different agreements and / or contracts required for studies according to the processes in place.
• Review of the different agreements and / or contracts with sponsor, vendors, suppliers, hospital…(master service agreements, statement of work, quality agreements…) relating to clinical operations.
• Implement best practices and standards for trial management in collaboration with other members of the clinical operations team and the quality department, including development  of SOPs.
• Validate the clinical trials support documents (monitoring guide according to the risk- based approach, logistic procedures).
• Ensure that clinical trials are conducted in compliance with applicable regulatory requirements and are inspection ready.
• Plan clinical headcount and hiring needs to meet program workload demands.
• Ensure study issues and action items are addressed and closeout appropriately and in compliance with study management plans.
• Study budget management and oversight of vendor and site payments in collaboration with the Clinical Project Manager.
• Supervise the processes for studies’ budget follow-up and control with the finance team;
• Prioritization and reallocation of means / resources (human, financial, deadlines, materials…) according to the results and the strategy;
• Planning of clinical studies;
• Lead, motivate and mobilize a team of multidisciplinary collaborators;
• Optimize the organization of work, work processes, the means used, plan and evaluate the results;
• Human resources management of clinical operations department (recruitment, evaluation, training…);
• Define priorities for action and allocation of means / resources / deadlines;
• Evaluate, develop and recognize the collaborators of his/her organization;
• Know how to prevent and / or prioritize possible conflicts and tensions.